Feasibility of TEE During Cardiac Arrest in Dutch Emergency Departments

June 26, 2024 updated by: Medical Centre Leeuwarden

Feasibility of Transesophageal Echocardiography in Patients With Cardiac Arrest in Emergency Departments in the Netherlands

The goal of this feasibility study is to learn if Dutch ED providers are able to use transesophageal echocardiography during cardiac arrest.

The main question it aims to answer is:

• are the ED providers able to determine the area of maximal compression of the heart using TEE

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Point-of-care ultrasound is a valuable diagnostic tool during cardiopulmonary resuscitation (CPR) in cardiac arrest and its use is recommended by international guidelines. Transthoracic echocardiography (TTE) is most commonly used, but has certain limitations. Image acquisition can be challenging due to patient specific factors such as body habitus. Also image quality may be impacted by the limited acquisition time during CPR pulse checks. Furthermore, observational data suggests that pulse checks are prolonged due to TTE, while minimizing interruption of chest compressions is emphasized for better CPR outcomes in the guidelines. Transesophageal ultrasound (TEE) is a possible alternative for TTE. It has the theoretical advantage of superior image quality and thereby possible reductions of chest compression delays. Furthermore, TEE gives the opportunity determine which part of the heart is compressed most effectively, which is referred to as the area of maximal compression (AMC). Animal studies showed that an AMC located over the left ventricle positively influenced hemodynamics and return of spontaneous circulation (ROSC) compared to an AMC over the aortic root. In human studies, data also suggests that AMC located on the left ventricle, as measured by TEE, may positively influence prognosis.

In the Netherlands, TEE is currently not used in emergency departments during cardiac arrest. The purpose of this study is to investigate if point-of-care TEE can be used effectively and safely by providers and teams that have not previously used this modality. Given the paramount importance of quality of chest compressions, the ability of the providers to assess the location of the AMC will be the main focus of this feasibility study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934AD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with cardiac arrest > 18 year in the emergency department.

Exclusion Criteria:

  • Patients with known upper gastro-intestinal malignancy or strictures, previous upper gastro-intestinal surgery or radiation, or known esophageal varices.
  • Patient with a do-not-resuscitate order, pregnant patients and traumatic cardiac arrest.
  • No trained TEE provider available.
  • ROSC at arrival.
  • Decision by the team to stop resuscitation at arrival at the emergency department due of prognosis.
  • Other life saving interventions which are prioritized over TEE by the resuscitation team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEE as POCUS modality.
TEE will be performed during cardiac arrest.
Diagnostic test: Transoesophageal echocardiography (TEE)
TEE is a diagnostic modality in which an ultrasound probe is inserted via the oesophagus in order to visualize the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of maximal compression (AMC)
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
The percentage of patients in which providers are able to determine the location of the AMC during cardiac arrest.
First 30 minutes of cardiac arrest treatment in the ED.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Location of AMC
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
The echographic location of the AMC, subcategorised as: left ventricle, left ventricular outflow tract/aortic root, other, not able to determine AMC
First 30 minutes of cardiac arrest treatment in the ED.
Accuracy of AMC
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
Accuracy of AMC defined as correlation between providers interpretation of AMC and reviewers interpretation of AMC
First 30 minutes of cardiac arrest treatment in the ED.
Safety of TEE
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
Incidence of complications of TEE
First 30 minutes of cardiac arrest treatment in the ED.
Intubation
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
Need for intubation for using TEE and duration of intubation
First 30 minutes of cardiac arrest treatment in the ED.
Time to image
Time Frame: First 30 minutes of cardiac arrest treatment in the ED.
Time from start ED treatment to first TEE image
First 30 minutes of cardiac arrest treatment in the ED.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Collaborators

Onze Lieve Vrouwe Gasthuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDTEE2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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